Z-0697-05

Automatic Cutting Needle, Model: NAC-1820B, Size 18 GA x 20 CM, Lot: xxxx, Single Use: Ethylene Oxide...

Name: Z-0697-05 Automatic Cutting Needle, Model: NAC-1820B, Size 18 GA x 20 CM, Lot: xxxx, Single Use: Ethylene Oxide...
Creator: Remington Medical Inc.
Published: 2005-02-15
License: https://open.fda.gov/license/

Remington Medical / initiated 2005-02-15 / Terminated

FDA source

Remington Medical Inc. began a recall of Automatic Cutting Needle, Model: NAC-1820B, Size 18 GA x 20 CM, Lot: xxxx, Single Use: Ethylene Oxide sterilized. Remington Medical, Inc., Alpharetta, GA 30005 on 2005-02-15. The reason FDA records is "The stylet hub detaches from the stylet needle". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0697-05
Status: Terminated
Initiated: 2005-02-15
Posted: 2005-04-08
Terminated: 2005-05-17
Recalling firm: Remington Medical
Product: Automatic Cutting Needle, Model: NAC-1820B, Size 18 GA x 20 CM, Lot: xxxx, Single Use: Ethylene Oxide sterilized. Remington Medical, Inc., Alpharetta, GA 30005.
Product code: KNW Instrument, Biopsy
Reason for recall: The stylet hub detaches from the stylet needle.
FDA root cause: Other
Action: Consignees were notified by letter on 02/15/2005.
Quantity in commerce: 1737 units
Distribution: Nationwide
Product codes and lots: Lot number 043351 & 043272

Product code KNW

K982401Class IIProstate Biopsy NeedleRemington Medical, Inc. / cleared 1998-09-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)